Famotidine
- Product NDC
- 50383-913
- 11-digit product format
- 503830913
- Labeler code
- 50383
- Product ID
- 50383-913_f448e568-540e-4027-be47-e7a5aa1051d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Akorn
- Application
- ANDA201995
- Marketing category
- ANDA
- Marketing start
- 2016-03-16
- Substance
- FAMOTIDINE
- Active strength
- 40 mg/5mL
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Famotidine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FAMOTIDINE | 40 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QZO15J2Z8 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50383-913-40 | Famotidine | 1 in 1 CARTON | POWDER, FOR SOLUTION | 1 | | 6 |
| 50383-913-40 | Famotidine | 50 mL in 1 BOTTLE, GLASS | POWDER, FOR SOLUTION | 50 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50383-913 | FAMOTIDINE POWDER, FOR SOLUTION [AKORN] | 6 | Current NDC, Legacy NDC, 2 package rows | 20220323_354a5a02-45cb-4ab0-88ee-6635d5a43b01.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50383-913-40 | 50383091340 | 1 BOTTLE, GLASS in 1 CARTON (50383-913-40) / 50 mL in 1 BOTTLE, GLASS | 2016-03-16 | 0000-00-00 | No | No | Current |